MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Cardiogenic Shock (2262)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Mean age, 62.6.Gender male, 70.4%.Race white, 86.1%.Date of event and implant date: dates estimated.The devices remain in patients.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other patient effect of death mentioned in the article is filed under a separate medwatch report.Article titled: uptake of drug-eluting bioresorbable vascular scaffolds in clinical practice an ncdr registry to practice project.

Event Description

It was reported through a research article identifying absorb bioresorbable vascular scaffold (bvs) that may be related to strokes, coronary artery bypass grafts, cardiogenic shock, and bleeding events.Titled uptake of drug-eluting bioresorbable vascular scaffolds in clinical practice.An ncdr registry to practice project.

Manufacturer Narrative

Internal file number: (b)(4).Unique device identifier (udi): in the absence of reported part number, udi cannot be calculated.There was no reported device malfunction and the product was not returned.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effects of cerebrovascular accident and shock, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, electronic instructions for use (eifu), are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8698154
• MDR Text Key: 148071587
• Report Number: 2024168-2019-04693
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 63 YR